Fenoglide (Page 6 of 7)
14.2 Severe Hypertriglyceridemia
The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients. Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 500 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate at dosages equivalent to 120 mg FENOGLIDE (fenofibrate) Tablets per day decreased primarily very low density lipoprotein (VLDL) triglycerides and VLDL cholesterol. Treatment of patients with elevated triglycerides often results in an increase of LDL-C (see Table 5).
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| Study 1 | Placebo | Fenofibrate | ||||||
| Baseline TG levels350 to 499 mg/dL | N | Baseline(Mean) | Endpoint(Mean) | %Change(Mean) | N | Baseline(Mean) | Endpoint(Mean) | %Change(Mean) |
| Triglycerides | 28 | 449 | 450 | -0.5 | 27 | 432 | 223 | -46.2* |
| VLDL Triglycerides | 19 | 367 | 350 | 2.7 | 19 | 350 | 178 | -44.1* |
| Total Cholesterol | 28 | 255 | 261 | 2.8 | 27 | 252 | 227 | -9.1* |
| HDL Cholesterol | 28 | 35 | 36 | 4 | 27 | 34 | 40 | 19.6* |
| LDL Cholesterol | 28 | 120 | 129 | 12 | 27 | 128 | 137 | 14.5 |
| VLDL Cholesterol | 27 | 99 | 99 | 5.8 | 27 | 92 | 46 | -44.7* |
| Study 2 | Placebo | Fenofibrate | ||||||
| Baseline TG levels500 to 1500 mg/dL | N | Baseline(Mean) | Endpoint(Mean) | %Change(Mean) | N | Baseline(Mean) | Endpoint(Mean) | %Change(Mean) |
| Triglycerides | 44 | 710 | 750 | 7.2 | 48 | 726 | 308 | -54.5* |
| VLDL Triglycerides | 29 | 537 | 571 | 18.7 | 33 | 543 | 205 | -50.6* |
| Total Cholesterol | 44 | 272 | 271 | 0.4 | 48 | 261 | 223 | -13.8* |
| HDL Cholesterol | 44 | 27 | 28 | 5.0 | 48 | 30 | 36 | 22.9* |
| LDL Cholesterol | 42 | 100 | 90 | -4.2 | 45 | 103 | 131 | 45.0* |
| VLDL Cholesterol | 42 | 137 | 142 | 11.0 | 45 | 126 | 54 | -49.4* |
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